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Clinical guidance

FDA advice on metformin is curbing its use

The US Food and Drug Administration (FDA) advice on the use of metformin is curbing its use. The low rate of metformin is due to discrepancies between FDA and clinical guidelines, researchers believe

Source: Wikimedia Commons

Discrepancies between US Food and Drug Administration advice and clinical guidelines is curbing appropriate metformin use, researchers believe

The US Food and Drug Administration (FDA) states that metformin is contraindicated in people with serum creatinine levels over a certain threshold. However, the criteria are considered overly conservative by bodies such as the American Diabetes Association, which argues that estimated glomerular filtration rate (eGFR) is a better measure of renal function.

To investigate, researchers examined data on more than 11.5 million participants taking oral diabetes drugs (JAMA Internal Medicine, online, 5 January 2015)[1]. Among those with an eGFR of 30–60mL/min — at which metformin is generally contraindicated but professional guidelines support cautious use — metformin was used by only around 50% of patients.

The low rate of metformin use is caused, at least in part, by the discrepancy between the FDA label and clinical guidelines, the researchers believe. They conclude: “The FDA is overdue to revisit the contraindication to metformin use in patients with renal insufficiency.” 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067599

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